[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"soft-tissue-sarcomas\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:soft-tissue-sarcomas":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,40,62,96,126,149],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100627129","phase-1-a-phase-i-study-of-pazopanib-in-combination-with-trabectedin-ipilimumab-and-nivolumab-trapin-in-pediatric-and-young-adult-patients-with-recurrent-soft-tissue-sarcomas-100627129",false,"NCT07444619","A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young Adult Patients With Recurrent Soft Tissue Sarcomas","Inclusion Criteria:\n\nAll Recurrent STS are eligible for enrollment. All laboratory studies will need to be complete within 7 days prior to initiating protocol therapy. All imaging studies will need to be done within 28 days prior to starting treatment.\n\n1. Age: Patients must be \\> 1 year of age and . 30 years of age at time of initiation of protocol therapy.\n2. Diagnosis: Patients have a histologically or radiographically confirmed relapsed or refractory STS.\n3. Disease Status: Patients must have evaluable disease.\n\n   a. Patients may have CNS metastases at study entry, if they are previously treated or stable (defined by not requiring initiation or the need for increased steroids for 7 days).\n4. Performance Level: Karnofsky . 50% for patients \\> 16 years old, and Lansky . 50 for patients 1-16 years old. (See Appendix I)\n5. Prior Therapy: Patients may have received prior therapy including single-agent pazopanib or trabectedin. Patients may not have previously been treated with combination therapy of pazopanib and trabectedin.\n\n   a. Patients must be fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. Delayed toxicities from chemotherapy (e.g. requiring electrolyte replacement, alopecia) will be permitted as long as they are stable or improving and approved by the study PI. i. Hematopoietic growth factor: At least 7 days must have elapsed since the last administration of filgrastim, or 14 days since administration of pegfilgrastim. ii. XRT: At least 7 days since the last dose of local palliative radiation therapy. Greater than 6 months must have elapsed since the last day of treatment if given total body irradiation, craniospinal irradiation. iii. Autologous or Allogenic Stem Cell Transplant: Complete resolution of graft versus host disease and no current need for immunosuppressive medication. Greater than 3 months must have elapsed since engraftment and no longer requiring transfusion of platelets or injection of colony stimulating factors.\n6. Organ Function Requirements a. Bone Marrow Function: i. Peripheral absolute neutrophil count (ANC) . 750\u002FƒÊL ii. Platelet count . 75,000\u002FƒÊL (no platelet transfusion within 7 days prior to obtaining laboratory result) b. Adequate Renal Function: i. Creatinine clearance or glomerular filtration rate . 70ml\u002Fmin\u002F1.73m2 (calculated or measured as appropriate for age and level of concern by treating MD) c. Adequate Liver Function: i. Total bilirubin . 1.5x upper limit of normal (ULN) for age ii. SGPT (ALT) . 3 x ULN iii. Serum albumin . 2gm\u002FdL Due to the risk of hepatic injury, including fatal hepatic failure, temozolomide should not be administered if total bilirubin is \\>2.0 mg\u002Fdl or SGPT(ALT)\\> 3 x ULN.\n\nExclusion Criteria:\n\n* Significant organ dysfunction, not meeting inclusion criteria.\n* Pediatric subjects who are considered wards of some entity.\n* Pregnancy or Breast-Feeding Pregnant or breast-feeding woman will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal\u002Fhuman studies.\n* Concomitant Medications:\n\n  1. Growth factor: Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days.\n  2. Investigational Drugs: Patients who are currently receiving another investigational drug. (Please refer to section 4.1, Prior Therapy)\n  3. Anti-cancer Agents: Patients who are currently receiving other anti-cancer agents. (Please refer to section 4.1, Prior Therapy)\n  4. Medication Allergy:\n\n  i. Allergy or intolerance to agents on this protocol: Trabectedin. Pazopanib, Ipilimumab or Nivolumab e. Infection: Patients who have uncontrolled infection, positive blood cultures within the past 48 hours, or receiving treatment for Clostridium difficile infection.\n* Known history of human immunodeficiency virus (HIV) infection\n* Known active infection of hepatitis B or Hepatitis C virus","ALL","1 Year","30 Years",{"count":19,"type":20},18,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this study is to build on the experience of the SAINT trial by evaluating the safety and efficacy of the addition of pazopanib to their published chemotherapy regimen.",[26],"Soft Tissue Sarcomas","NOT_YET_RECRUITING","2026-02-26",{"date":30,"type":31},"2026-03-03","ACTUAL",{"date":33,"type":20},"2026-08-31",{"date":35,"type":20},"2033-12-31",{"name":37,"class":38},"M.D. Anderson Cancer Center","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":46,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":39},"100539790","phase-1-a-phase-i-trial-of-combination-gemcitabine-and-nab-sirolimus-in-advanced-leiomyosarcomas-or-advanced-soft-tissue-sarcomas-with-tsc2-or-tsc1-loss-of-function-mutations-or-deletions-100539790","NCT06308419","A Phase I Trial of Combination Gemcitabine and Nab-Sirolimus in Advanced Leiomyosarcomas or Advanced Soft-Tissue Sarcomas With TSC2 or TSC1 Loss-of-function Mutations or Deletions","Inclusion Criteria:\n\n1. Patients must have histologically confirmed leiomyosarcoma or sarcoma with TSC2 or TSC1 loss-of-function mutations or deletions based on standard-of-care genomic testing.\n2. Sarcoma that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective. One prior standard systemic therapy is required for leiomyosarcoma (LMS) Patients.\n3. Prior gemcitabine-based chemotherapy is allowed if the last dose of gemcitabine was given more than 12 months prior to the first dose of treatment on trial, there was no progression of disease while on treatment with gemcitabine, and there was intolerable toxicity.\n4. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.\n5. Age ≥18 years. Because no dosing or adverse event data are currently available on the use of nab-sirolimus in combination with gemcitabine in patients \\\u003C18 years of age, children are excluded from this study.\n6. ECOG performance status ≤2 (Karnofsky ≥60%,).\n7. Life expectancy of \\>3 months, as determined by the investigator.\n8. Patients must have adequate organ and marrow function as defined below:\n\n   i. absolute neutrophil count ≥1,500\u002FmcL ii. platelets ≥100,000\u002FmcL iii. hemoglobin ≥9 gm\u002FdL iv. total bilirubin ≤ 2 x institutional upper limit of normal (ULN) (except patients with Gilbert's syndrome, who must have total bilirubin \\\u003C 3.0 mg\u002FdL) v. AST(SGOT)\u002FALT(SGPT) ≤2 × institutional ULN vi. eGFR (calculated by CKD-EPI) ≥ 60 mL\u002Fmin vii. Serum triglyceride \\\u003C300 mg\u002FdL viii. Serum cholesterol \\\u003C350 mg\u002FdL\n9. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n10. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For Participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n11. Patients with Human Immunodeficiency Virus (HIV) with a viral load \\\u003C400copies\u002FmL, no IADS-defining illness within 12 months of enrollment, and no CYP3A4 inducers or inhibitors in the antiretroviral treatment.\n12. Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n13. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n14. The effects of nab-sirolimus on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). Negative serum HCG will be required before study drug administration. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n    Postmenopausal (no menses in greater than or equal to 12 consecutive months). History of hysterectomy or bilateral salpingo-oophorectomy. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range).\n\n    History of bilateral tubal ligation or another surgical sterilization procedure.\n\n    Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Patient\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n15. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion:\n\n1. Patients who are receiving any other investigational agents or have received any other investigational agent within 3 weeks prior to enrollment.\n2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to nab-sirolimus or gemcitabine.\n3. Use of strong inhibitors and inducers of CYP3A4 within the 7 days prior to receiving the first dose of nab-sirolimus. Additionally, use of any known CYP3A4 substrates with narrow therapeutic window (such as fentanyl, alfentanil, astemizole,cisapride, dihydroergotamine, pimozide, quinidine, terfanide) within the 7 days prior to receiving the first dose of nab-sirolimus.\n4. Patients with active concurrent malignancy.\n5. Recent stroke or thromboembolic event (within 6 months) requiring anticoagulation that cannot be interrupted. Non-life threatening deep venous thrombosis on stable anticoagulation within 6 months is allowed.\n6. Active gastro-intestinal bleeding.\n7. Pre-existing thyroid abnormality is allowed provided thyroid can be controlled with medication.\n8. Prior treatment with radiotherapy (including radio-labeled spheres and\u002For cyberknife, hepatic arterial embolization (with or without chemotherapy) or cyrotherapy\u002Fablation) is allowed if these therapies did not affect the areas of measurable disease being used for this protocol.\n9. Uncontrolled diabetes mellitus as defined by HbA1c \\>8% despite adequate therapy.\n10. Evidence of severe or uncontrolled systemic disease or any other concurrent condition, including psychiatric, that would significantly limit the ability to participate safely in this study.\n11. Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with nab-sirolimus, breastfeeding should be discontinued if the mother is treated with nab-sirolimus. These potential risks may also apply to other agents used in this study.\n12. Prior treatment of sarcoma with mTOR inhibitors.\n13. Vulnerable populations will not be enrolled.","18 Years",{"count":19,"type":20},[23],"To find a recommended dose of gemcitabine and nab-sirolimus that can be given in combination to participants with advanced leiomyosarcomas or soft-tissue sarcomas.",[51,52],"Leiomyosarcoma","Soft-tissue Sarcomas","RECRUITING","2026-02-24",{"date":56,"type":31},"2026-02-25",{"date":58,"type":31},"2024-08-14",{"date":60,"type":20},"2031-02-01",{"name":37,"class":38},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":15,"minAge":46,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":75,"conditions":76,"keywords":82,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":39},"100581413","phase-2-io-combined-with-ai-as-first-line-treatment-for-patients-with-soft-tissue-sarcomatais-100581413","NCT06849986","IO Combined With AI as First-line Treatment for Patients With Soft Tissue Sarcoma(TAIS)","Tislelizumab Combined With Liposomal Doxorubicin and Ifosfamide as First-line Treatment for Patients With Specified Subtypes of Unresectable or Metastatic Soft Tissue Sarcoma: a Multi-center, Single-arm, Prospective Phase II Clinical Trial","TAIS","Inclusion Criteria:\n\n* Age 18 to 75 years, regardless of gender;\n* Patients with histopathologically confirmed undifferentiated sarcoma (except small round cell undifferentiated sarcoma), synovial sarcoma, angiosarcoma, fibrosarcoma, smooth muscle sarcoma, liposarcoma (except well differentiated liposarcoma), pleomorphic rhabdomyosarcoma, malignant peripheral nerve sheath meningiomas, desmoplastic small round cell tumor, not other specified (NOS), SMARCA4-deficient sarcoma, malignant phyllodes tumor of the breast, intimal sarcoma.\n* Patients with locally advanced disease that is not amenable to surgery\u002Fradiation therapy or with recurrent\u002Fmetastatic disease;\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1;\n* Expected survival of more than 3 months;\n* Within 7 days prior to screening (including day 7), laboratory test data requirements: neutrophil count ≥1.5×10⁹\u002FL, platelet count ≥90×10⁹\u002FL, hemoglobin ≥90g\u002FL (no blood transfusion within 14 days), serum total bilirubin ≤1.5 times the upper limit of normal (ULN); ALT and AST ≤2.5× ULN (≤5× ULN for patients with liver metastases); serum creatinine ≤1.5× ULN or creatinine clearance rate ≥50ml\u002Fmin;\n* Presence of measurable lesions according to RECIST 1.1 criteria;\n* The subject (or their legal representative\u002Fguardian) must sign an informed consent form, indicating that they understand the purpose of this study, are aware of the necessary procedures, and are willing to participate in this study.\n\nExclusion Criteria:\n\nAny of the following conditions will result in exclusion from the study:\n\n* Previous treatment for advanced soft tissue sarcoma, except for those who relapsed more than six months after adjuvant therapy with a cumulative dose of doxorubicin ≤300mg\u002Fm2;\n* Received any experimental or anti - tumor drugs within 4 weeks prior to enrollment;\n* Previously received any anti - PD - 1, anti - PD - L1, anti - PD - L2, anti - CD137, or anti - CTLA - 4 antibody treatment, or any other antibodies or drugs specifically targeting T - cell co - stimulation or checkpoint pathways;\n* History of other tumors within the past five years, except for cured cervical cancer or skin basal cell carcinoma; for patients with post - radiation sarcoma, another primary tumor must have no recurrence or metastasis;\n* Symptomatic brain or meningeal metastasis (unless the patient has been treated for more than 6 months, with negative imaging results within 4 weeks prior to enrollment, and stable tumor - related clinical symptoms at the time of enrollment);\n* Clinically significant active bleeding;\n* Pregnant or lactating women; women of childbearing potential who have not taken adequate contraceptive measures;\n* Alcohol abuse or drug addiction;\n* Patients with active autoimmune diseases or a history of such diseases that may recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or those at high risk (such as patients who have undergone organ transplantation and require immunosuppressive therapy). Autoimmune hypothyroidism requiring only hormone replacement therapy or skin diseases not requiring systemic treatment are excluded;\n* Patients who need to receive systemic corticosteroids (equivalent to \\>10mg prednisone\u002Fday) within 14 days prior to enrollment or during the study, or those who require other immunosuppressive drug treatment. The use of topical or inhaled corticosteroids, or short - term (≤7 days) use of corticosteroids for prevention or treatment of non - autoimmune, non - frequent allergic diseases is excluded;\n* Failure of important organs or other severe diseases, including interstitial pneumonia, clinically significant coronary artery disease, cardiovascular disease, or myocardial infarction, congestive heart failure, unstable angina, symptomatic pericardial effusion, or unstable arrhythmia within 6 months prior to enrollment;\n* History of human immunodeficiency virus infection, or other acquired or congenital immune deficiency diseases, or history of organ transplantation or stem cell transplantation;\n* Patients with active chronic hepatitis B or active hepatitis C. HBV carriers, those with stable hepatitis B after drug treatment (DNA titer ≤10\\^3 copies\u002Fml), and those with cured hepatitis C (HCV RNA negative) are eligible for enrollment;\n* Severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation, or other concomitant diseases that, in the opinion of the investigator, seriously endanger the safety of the patient or affect the patient's ability to complete the study.","75 Years",{"count":72,"type":20},45,[74],"PHASE2","This study will enroll patients with specific subtypes of unresectable or metastatic soft tissue sarcoma, and will combine tislelizumab with the standard chemotherapy of liposomal doxorubicin and ifosfamide to initially explore the efficacy and safety.",[26,77,78,51,79,80,81],"Angiosarcoma","Fibrosarcoma","Pleomorphic Liposarcoma","Malignant Peripheral Nerve Sheath Tumor (MPNST)","Desmoplastic Small Round Cell Tumor",[83,84,85,86],"soft tissue sarcoma","tislelizumab","doxorubicin","ifosfamide","2026-01-07",{"date":89,"type":31},"2026-01-08",{"date":91,"type":31},"2025-02-25",{"date":93,"type":20},"2029-12-31",{"name":95,"class":38},"Fudan University",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":15,"minAge":46,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":108,"conditions":109,"keywords":110,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100269625","cinsarc-signature-and-correlation-with-hemotherapy-efficacy-in-soft-tissue-sarcomas-a-biomarker-study-100269625","NCT02789384","CINSARC Signature and Correlation With Hemotherapy Efficacy in Soft-tissue Sarcomas. A Biomarker Study.","Prognostic Value of the CINSARC (Complexity Index in Sarcoma) Signature and Correlation With Chemotherapy Efficacy in Soft-tissue Sarcomas. A Biomarker Study. (NEOSarcomics )","NEOSarcomics","Inclusion Criteria:\n\n1. Histologically confirmed soft-tissue sarcoma by central review, except if the diagnosis was already confirmed by the RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) Network,\n2. Available archived frozen tumor tissue sample or patient consenting to undergo a biopsy of the tumour for research purpose,\n3. Non-metastatic disease, for which the use of chemotherapy to \"downstage\" the sarcoma prior to surgery, is assumed to result in better local tumor control by the multidisciplinary sarcoma team of one of the French reference centers involved in this study,\n4. Age ≥ 18 years,\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1,\n6. Measurable disease according to RECIST v1.1 outside any previously irradiated field,\n7. Neoadjuvant anthracycline-based chemotherapy proposed as the best option by the multidisciplinary sarcoma team of one of the French reference centers involved in this study,\n8. No prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma,\n9. Voluntarily signed and dated written informed consents prior to any study specific procedure,\n10. Patients with a social security in compliance with the French Law relating to biomedical research (Article 1121-11 of French Public Health Code).\n\nExclusion Criteria:\n\n1. Pathological diagnosis different from a soft-tissue sarcoma,\n2. Histological subtypes: well-differentiated liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear-cell sarcoma, rhabdomyosarcoma,\n3. Previous treatment for the sarcoma,\n4. Contra-indication precluding the administration of chemotherapy as assessed by the investigator,\n5. Participation to a study involving a medical or therapeutic intervention in the last 30 days,\n6. Previous enrolment in the present study,\n7. Pregnant or breast feeding women,\n8. Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons.",{"count":105,"type":20},205,[107],"NA","This is a prospective observational biomarker study including patients with non-metastatic, soft-tissue sarcomas (STS) for whom neoadjuvant chemotherapy is considered as the best option by the multidisciplinary sarcoma team of one of the participating centers.",[52],[111,112,113,114,115],"soft-tissue sarcomas","CINSARC","biomarker","efficacy","pronostic","2025-11-24",{"date":118,"type":31},"2025-12-02",{"date":120,"type":31},"2016-06",{"date":122,"type":20},"2027-12",{"name":124,"class":38},"Institut Bergonié",10,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":15,"minAge":46,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":136,"conditions":137,"keywords":138,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":39},"100401343","phase-2-hypofractionated-radiotherapy-followed-by-surgical-resection-in-the-treatment-of-soft-tissue-sarcomas-100401343","NCT04506008","Hypofractionated Radiotherapy Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas","Prospective Observational Trial of Two Neoadjuvant Hypofractionated Radiotherapy Regimens Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas","Inclusion Criteria:\n\n* Histologic diagnosis of a soft tissue sarcoma of extremity, pelvis, chest wall or trunk\u002Fabdominal wall (non-retroperitoneal location)\n* ECOG performance status 0-2\n* Patient must be deemed able to comply with radiation treatment and surgery\n\nExclusion Criteria:\n\n* History of prior radiation to the same area to be irradiated\n* Pregnancy\n* Active collagen vascular disease or patients genetically predisposed to increased radiation related side effects",{"count":134,"type":20},40,[74],"The trial will use neoadjuvant hypofractionated radiotherapy followed by surgical resection in the treatment for soft tissue sarcoma. It will allow patients to be treated over a shorter course (5 or 15 days of radiation) compared to the traditional 5 week regimen. It is proposed that this will be possible without increasing the risk of wound complication or local recurrence compared with a traditional 5 week course of pre-operative radiation.",[26],[139],"Hypofractionated Radiotherapy","2025-03-24",{"date":142,"type":31},"2025-03-28",{"date":144,"type":31},"2021-03-02",{"date":146,"type":20},"2027-06",{"name":148,"class":38},"Vanderbilt-Ingram Cancer Center",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":15,"minAge":46,"maxAge":70,"enrollmentInfo":156,"targetDuration":4,"studyType":21,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":39},"100561725","phase-2-the-total-neoadjuvant-therapy-for-soft-tissue-sarcoma-of-the-extremities-100561725","NCT06593899","The Total Neoadjuvant Therapy for Soft Tissue Sarcoma of the Extremities","The Total Neoadjuvant Therapy for Hypofractionated Radiotherapy Combined with AI Regimens in Soft Tissue Sarcoma of the Extremities: a Phase 2 Single Arm Multicenter Study","Inclusion Criteria:\n\n1. Primary soft tissue sarcoma of the extremities, with one of the following characteristics: high grade, ≥5cm or deep tumor, the need for neoadjuvant radiotherapy was determined after multidisciplinary consultation.\n2. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.\n3. Age 18-75 years old.\n4. Histologic diagnosis of soft tissue sarcoma.\n5. Can tolerate radiotherapy and AI regimen treatment.\n6. The function of major organs is normal.\n\nExclusion Criteria:\n\n1. There were no patients with gross tumors after unplanned mass resection in another hospital.\n2. Patients with other comorbidities cannot use AI chemotherapy: drug allergy, active bleeding, ulcers, intestinal perforation, intestinal obstruction, uncontrollable hypertension, grade III-IV cardiac insufficiency (NYHA standards), severe liver and renal insufficiency ( Level IV) etc.\n3. New malignant tumors within 5 years (except cervical carcinoma in situ or early cutaneous basal cell carcinoma).\n4. Pathological types: nonpleomorphic rhabdomyosarcoma, Ewing sarcoma.\n5. Soft tissue sarcoma curable by simple expansion.\n6. Previous history of radiotherapy to the same site.\n7. Combined with distant metastasis (M1) or lymph node metastasis (N1).\n8. Have other severe medical comorbidities that preclude surgery or participation in the study.\n9. Previous exposure to chemotherapy.",{"count":157,"type":20},51,[74],"For localized soft tissue sarcomas (STS) of the extremities, limb-sparing or conservative surgery with perioperative radiotherapy (RT) is the standard of care. However, several challenges persist. Notably, there are exceedingly high rates of distant metastatic recurrence even after surgical resection and RT, and conventional fractionated radiotherapy has a prolonged duration (5-6 weeks). With advancements in RT technology, the gradual expansion of hypofractionated radiotherapy regimens enables significantly shorter treatment durations. Promising recent reports on 1-week hypofractionated RT regimens, such as the 5X5 Gy RT regimens, have demonstrated reasonable local control and acceptable toxicity in resectable STS.Addressing the challenge of distant metastasis, previous studies have indicated that AI regimens are expected to eliminate micrometastases and improve survival in patients with STS at a high risk of distant relapse. Therefore, the goal of this clinical trial is to investigate whether hypofractionated RT combined with a sequential chemotherapy（AI regimens）can enhance short-term treatment efficacy for extremity STS patients without compromising local control rates and increasing related toxicities",[26],"2024-09-10",{"date":163,"type":31},"2024-09-19",{"date":165,"type":31},"2024-05-01",{"date":167,"type":20},"2026-07-01",{"name":169,"class":38},"Fujian Medical University Union Hospital"]